GS1 standardsPrimer session31st Global GS1 Healthcare conferenceBerlin, Germany
04 April 2017
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Agenda of the session
1.GS1 Healthcare, the global perspective Chuck Biss
2.Automatic Identification Data Capture Chuck Biss
3.Master Data Management and Global Location Numbers Pete Alvarez
5.Electronic Data Interchange (EDI) Craig Alan Repec
6.Event-Based Traceability (EPCIS) Craig Alan Repec
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Chuck Biss, Senior Director, ADIC Healthcare, GS1 Global Office
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GS1 Healthcare, the global perspective
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GS1, most widely used standards
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GS1 ensures end-to-end visibility in the supply chain
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GS1 enables
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• Patient safety • Lower costs
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Global reach, local presence
110+ Member OrganisationsMore than 1,000,000 member
companies150 countries served2,000 + employees
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GS1 Healthcare - Voluntary, Global Healthcare User Group
To lead the healthcare sector to the successful development and implementation of global standards by bringing together experts in
healthcare to enhance patient safety and supply chain efficiencies.
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Our vision 2005
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The vision of GS1 Healthcare is to be the recognised, open and
neutral source for regulatory agencies, trade organisations and other
similar stakeholders seeking input and direction for globalstandards in healthcare for
patient safety supply chainsecurity & efficiency traceability product data
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GS1 Healthcare: an expanding, committed community of globally engaged stakeholders…
…and there are many more companies working with GS1 at a local level
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…as well as with leading healthcare providers to implement…
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…and with global organisations…
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Health Level 7International
Clinical DataInterchange Standards
Consortium
World HealthOrganization
World CustomsOrganization
International Council for
Commonality in Blood Banking Automation
International HospitalFederation
InternationalSociety for Quality
in Healthcare
Integrating the
Healthcare Enterprise
InternationalHealth Terminology
SDO
InternationalOrganisation for Standardisation
EuropeanCommittee forStandardization
Digital Imaging and Communications in
Medicine
European Association of
Hospital Pharmacists
European Federation of
Pharmaceutical Industries and Associations
European Medical Devices Industry
Association
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Chuck Biss, Senior Director, ADIC Healthcare, GS1 Global Office
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Automatic Identification and Data Capture in Healthcare ...an AIDC short course
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GS1 standards
GS1 standards for identifying, capturing, and sharing information—about products, business locations, and more—make it possible for companies to speak the same language, connect with each other and move their business forward.
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Identify Capture Share
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Automatic Identification & Data Capture (AIDC)“Automatic Identification and Data Capture (AIDC) refers to the methods of automatically identifying objects, collecting data about them, and entering that data directly into computer systems (i.e., without human involvement).” Wikipedia, 2009
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GS1 standards… and AIDC
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Pete will cover next…
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AIDC for Healthcare… the Vision
EVERY item hasONE set of key identification data carried in
ONE data carrierable to be scanned by EVERYONE
at every key process step…
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Pharma / Vaccine / Nutritional Medical devices
Retail Non-retail
Scope - All healthcare products...
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Single Unitpackage
Primarypackage
Secondarypackage
Case /Shipper
(Tertiary*)
Pallet(Tertiary*)
NOTE: * - Potentially a new defintion that is needed…Note: Images shown are for illustration example only, refer to local regulations and/or the latest version of the GS1 General Specification for more detail.
Scope – ID at all packaging levels...
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Scope - Data & Data Carriers...
Data – a few examples:• Global Trade Item Number (GTIN)• Expiry Date• Batch / Lot• Serial Number
Data Carriers – a few examples:
(21)123
GS1-128 & GS1 DataBar GS1 DataMatrix EPC / RFID
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GS1 Identification Keys
Foundation of the GS1 System…
Provide access to information held in computer files –Information about company/location, package, product, price, etc.
1234567891234
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GS1 Identification Keys…
• Unique• Non-
significant• International• Secure• Foundational
Item identifier =
Logistics unit identifier =
Location identifier =
…and there are more …
GTIN
SSCC
GLN
Global Trade Item Number
Serial Shipping Container Code
Global Location Number
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…but sometimes there is need to capture data beyond basic item ID…
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Item identifier Expiry date
Batch/Lot number
Serial number(21)123
Trade Item Attributes
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The GS1 General Specification includes 100+ “Application Identifiers” (“Key Attributes” or “AI’s”) for various use cases &
various sectors..however the Application Identifiers most commonly used at this time (in various
combinations) in Healthcare are:
01 GTIN (Global Trade Item Number)10 Batch / Lot11 Production Date17 Expiry Date21 Serial Number
GS1 Application Identifiers…
Note – Other than certain efficiency recommendations within the GS1 General Specifications, the order of AI’s is not significant and should not be mandated.
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GS1 Data carriers for Healthcare…
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GS1-128 & GS1 DataBar
Preferred options if:Package size allows
GS1 DataMatrixPreferred option if:
Large amounts of data in a smallspace
Variable information at high production rates
Direct part marking
EPC/RFIDAditional optionNon-line of sight
Large amounts of data
Imager based bar code scanners are needed in HC !!
Important note for new
implementations or systems
updates
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GS1 System Standards
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GS1 General Specifications – the ONE global standard for AIDC in Healthcare
• The core standards document of the “GS1 System”… describes how GS1 keys & data carriers should be used - Available online at: http://www.gs1.org/docs/barcodes/GS1_General_Specifications.pdf
GS1 Healthcare GTIN Allocation Rules – GTIN assignment in Healthcare
• A guide to GS1 ID Key assignment… the GS1 GTIN Allocation Rules presented in Healthcare related terms with Healthcare specific examples – Available online at: http://www.gs1.org/docs/gsmp/healthcare/GS1_Healthcare_GTIN_Allocation_Rules.pdf
Many countries have already adopted GS1 Standards… and we anticipate many more!
RevisedAnnually!!
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Throughout the conference sessions there will be AIDC related presentations… as examples (but not limited to):
Tuesday 14:00 – 15:30 – Bedside scanning• Mr. Rob Moss, Director of Professional Development, EAHP• Mr. Johannes Ros, Pharmacist, Gelre Hospital, Netherlands• Mr. Pascal Aulagnet, Market Client Partner, Europe Middle-East & Africa, Pfizer
Tuesday 16:00 – 17:30 – Hospital Implementation• Mr. Andrew Raynes, Barking, Havering and Redbridge University Hospitals NHS Trust,
UK• Mr. Terry Hoy, Regional Supply Chain Manager, South West Supply & Logistics, South
West Healthcare
Wednesday 14:00 – 15:30 – Ask the Experts: GS1 DataMatrix/HRI• Chuck Biss - Senior Director, AIDC Healthcare – GS1 Global Office
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AIDC this Week...
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Contact Information
Chuck Biss GS1 Global Office Senior Director, AIDC HealthcareT +1 315 252 5941M +1 315 480 [email protected]
Master Data Quality and Global Location Numbers
Inaccurate or bad data adds risk and cost
Peter Alvarez, Senior Director, Identification and Data Strategy, HealthcareGS1
4 April 2017
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Topics
• The Value of Trusted Data
• The Global Data Synchronisation Network
• Global Location Numbers & the GLN Service
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The value of trusted data
Source: The Value of Trusted Data - http://www.gs1.org/healthcare/share-data-gdsn
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Better patient care & improved efficiency
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Safer and better treatmentsTraceability
Seamless order to cash Warehouse management
Lower costs
Collaboration
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What happened to Master Data?
• Systems have evolved in “silos” over the last 40+ years
• The link between “process” and data was broken (remains so in many cases)
• Numerous efforts to “unify” data and process, or views of data – one use at a time
• So what? Businesses operated and so didhospitals
• Only when costs increase, profits fall, or a patient is negatively affected does the real impact of bad data become known!
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1970s
1990s
2000s
Original source: Gartner
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Digital and mobile disruption
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Data errors in healthcare
% of TotalData Error
Manu-facturer
Distributor GPO Healthcare provider
Missing Middle Levels of Packaging
15-20% 1-4% 20-25% 15-25%
Hard “Packaging Quantity” Errors
1% 1% 2% 2-5%
Unit of Measure Confusion/Misuse
2-6% 1-3% 2-5% Unknown
Missing Packaging—not Middle Level
3-8% 3-8% 3-7% 5%
Manufacturer Name Problems
NA 2-5% 1-4% 30%
Obsolete Products 1-4% 2-5% 1-8% 5-15%
Missing Product Brand Names
2-5% 5-10% 5-10% 20-25%
Incomplete Item Descriptions
5-15% 3-12% 5-15% 10-20%
Wrong Customer Unit Prices Unknown 1-2% NA 1-2%
Customer Paid More Than Lowest Contract Price
NA Unknown NA 3-6%
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U.S.A Department of Defense Study
Source: http://2016archive.gs1us.org/DesktopModules/Bring2mind/DMX/Download.aspx?command=core_download&entryid=933&language=en-US&PortalId=0&TabId=785
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Australian data crunch: The cost of bad data
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Source: https://www.gs1au.org/resources/publications/
Source: http://www.gs1.org/articles/1563/australian-healthcare-industry-data-crunch-report-reveals-high-cost-bad-quality-data
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Order-to-cash before data synchronisation
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1. Product Info sent
Errors in transposition
2. Product Info entered
Errors in TranslationErrors in Delivery / Transmission
Fax/ Mail/File transferIncorrectItem #sPricesDescQty
Supplier / Broker Buyer
6. Despatch Advice
3. Purchase Order
7. Goods Delivered
5. Adjusted Purchase Order
4. Query Order Errors
11. Delayed Settlement
8. Query Delivery Errors / Claim for credit
9. Return Incorrect Goods
10. Adjusted Delivery
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The Global Data Synchronisation Network
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GDSN Information: http://www.gs1.org/gdsn
• 37 certified GSN Data Pools
• 1.8+ million healthcare products
• 3,500+ suppliers
• Published to 83 countries
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Order-to-cash after data synchronisation
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Supplier / Broker Buyer
6. Despatch Advice
7. Goods Delivered
3. Purchase Order
5. Adjusted Purchase Order
4. Query Order Errors
11. Delayed Settlement
8. Query Delivery Errors / Claim for credit
9. Return Incorrect Goods
10. Adjusted Delivery
1. Populates 2. Publishes
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The Global Locations Number (GLN) andthe GLN Service
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The problem with location identification
SAINT JOHN'S QUEENS HOSPITAL 1100004570208
ST JOHN'S QUEENS HOSPITAL 100084547
SAINT JOHNS QUEENS HOSPITAL JAOE
SAINT JOHN'S QUEEN HOSPITAL 50003000431
SAINT JOHN'S QUEEN’S HOSPITAL CA2053
ST. JOHN'S QUEENS HOSPITAL OM 12345
Many different namesdifferent location numbers for 1 hospital
Source: GS1 US
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Why use Global Location Numbers (GLN)
• A global standard for identification of legal entities and physical locations
• A GLN is an identification Key
• Vital for GS1 eCom messaging so that all parties and locations may be uniquely identified
• A pre-requisite for Global Data Synchronisation
Different locations in a hospital
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The GLN Service: Global exchange of GLN master data
GLNs are a vital component for the efficient and effective use of e-business messaging. GLNs should be used to identify all the locations and parties to simplify the automation of business messages.
The main use cases of GLN are Master Data and EDI.
Single point of access to GLN Master Data, globally, via the local GS1 Member Organisation
GLN Service
Germany
EcuadorSweden
USA
Hong Kong
Information: http://www.gs1.org/gln-services
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Data sessions this weekWednesday 14:00 – 15:30 – Panel Discussion: Medical Device Identification and Data Management• Linda Sigg, U.S. FDA• Terrie Reed, U.S. FDA• Georg Keller, B. Braun/Aesculap• Jackie Elkin, Medtronic, Inc.• Volker Zeinar, B. Braun
Thursday 10:15 – 10:40 - Master data management with GDSN• Michaela Berlich, University Hospital Schleswig-Holstein• Dr. Hajo Reissmann, University Hospital Schleswig-Holstein
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Contact Information
Peter Alvarez GS1 Senior Director, Identification and Data Strategy+1 609 557 [email protected]
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Craig Alan RepecSenior Manager, Supply Chain Visibility, EPCIS & RFID
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EDI in Healthcare
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PHYSICAL FLOW
INFORMATION FLOW
Information sharing
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SUPPLIER CUSTOMER
MASTER DATAE.G. CONTACT DETAILS,
PAYMENT TERMS
TRANSACTIONAL DATAE.G. ORDER, INVOICE
EVENT DATAE.G. WHERE IS MY DELIVERY?
GDSN
GS1 EDI
EPCIS
RFID/Barcodes Tagged Pallets & Cases
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GS1 EDI Standards
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EANCOM
GS1 XML
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EDI in Healthcare
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MANUFACTURERS WHOLESALERS
HOSPITAL MD
HOSPITAL PHARMA
RETAIL PHARMA
Place order: FORMAT 1PO; Issue Invoice: INVOICE
Place order: FORMAT 1 - PO; Issue Invoice: INVOICE
Place order: FORMAT 2PO; Issue Invoice: INVOICE
Place order: FORMAT 1 - PO; Issue Invoice: FORMAT 2 INVOICE
Place order: FORMAT 2 - PO; Issue Invoice: INVOICE; Deliver: FORMAT 2 DISPATCH ADVICE
Place order: FORMAT 2 – PO, INVOICE; Deliver: FORMAT 2 DISPATCH ADVICE
Place order: FORMAT 1PO; Issue Invoice: INVOICE
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EDI implementation drivers
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1 HELPING TO ENSURE QUALITY OF CARE
2 MEETING REGULATORY OR TRADING PARTNER REQUIREMENTS
3 FACILITATING PRODUCT TRACEABILITY
4 INCREASING EFFICIENCY, ACCURACY, REDUCING COST
5 ENABLING NEW BUSINESS PROCESSES
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Design Principles for GS1 EDI
• Master Data alignment• Foundational info must be agreed & shared pre-EDI• Use of GS1 globally unique identifiers – GS1 Keys• Only coded information (machine readable)
• Guidelines• Global guideline comprises core processes and data• Local guidelines add local requirements (e.g., regulatory)
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Global Guideline - Business contents and technical information separated
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1 HEALTHCARE BUSINESS PROCESS MODEL
2 BDS - BUSINESS DOCUMENT SPECIFICATION
3 BDS SUMMARY
4 MS EANCOM – MAPPING SPECIFICATION
5 MS XML– MAPPING SPECIFICATION
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Healthcare Business Process Model
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MAIN BUSINESS PROCESSES IN THE GUIDELINES
Master Data Order To Cash Consignment Stock
DESCRIBES BEST PRACTICE VIEW OF HC PROCESSES, INDEPENDENT OF TECHNOLOGIES AND STANDARDS
Published In Two Documents
Part I: Executive overview
Part II: Detailed process description of HC supply
chain information exchange
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How to use the global guidelinewhen creating local guidelines
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Agree on the process to start with
Global guide update
=
Agree on the data elements as described in the BDS
Create mapping using the mapping specification
Share with GS1 Global Office=
Applicable locally
Add local processes
Add additional info
Missing data?
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Craig Alan RepecSenior Manager, Supply Chain Visibility, EPCIS & RFID
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Event-Based TraceabilityEPCIS
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EPCIS: a GS1 “Share” standard
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EPCIS
CBV
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EPCIS, a GS1 open standard . . .
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• defines interfaces for capturing & sharing data
• defines a framework data model for event data
• helps create & share visibility data across enterprises
• enables services & solutions for supply chain visibility GS1 Keys identify the “what” & “where” of visibility events…• …encoded as data-carrier neutral EPCs• …even when used with GS1 barcodes (instead of RFID)
• Approved as ISO/IEC 19987 in July 2015
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Core Business Vocabulary (CBV)a GS1 “Share” standard
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• Companion standard to EPCIS
• Defines specific data values to populate EPCIS data model
• Ensures a common understanding of data semantics
• Anchors EPCIS events to business process context
• Critical to interoperability of EPCIS implementations
• Includes values & definitions for Standard Vocabularies
• Provides identification syntax rules for User Vocabularies
• Approved as ISO/IEC 19988 in July 2015
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Four dimensions of an EPCIS event
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WHAT objects are the subject of event?Individual objects (SGTIN) or groupings (GTIN + Lot/batch)
WHEN did this event take place?Date, time, time zone
WHERE did this happen, and where are the objects thereafter?Read Point (GLN) & Business Location (GLN)
WHY did this event take place?• Business step (e.g., “Shipping”)• Disposition (e.g, “in_transit”)
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EPCIS enables supply chain visibility
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• TrackingWhere are the pharmaceuticals I shipped?
• TracingWhere did this batch of pharmaceuticals come from?
• Chain of Custody (CoC) / Chain of Ownership (CoO)Which parties had custody of these pharmaceuticals?
• Asset Management & MaintenanceWhere are all of the hospital‘s balloon pumps?
• RecallWhere were meds produced on 14 April shipped to?
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EPCIS implementations 2017 and beyond
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• Food / Fresh Produce Packaging and Distribution
• Fish Packaging and Distribution
• Rolling Stock Visibility in Rail
• Maintenance, Repair & Overhaul (MRO) in Rail
• Asset management
• Apparel Stock-Taking & Cycle Counting
• Pharmaceutical chain-of-custody
• Hospital procedures / Bedside treatment / OR
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DSCSA – Drug Supply Chain Security Act
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Packaging level: Saleable units and homogeneous cases
Deadlines• 2015: Lot based• 2017: Serialisation by manufacturers and repackagers• 2023: Full traceability back to manufacturer or repackager
EPCIS explicitly mentioned in a 2014 USFDA draft guidance as a means for interoperable exchange of pharma traceability data
GS1 US Rx Guideline for DSCSA: www.GS1US.org/RxGuideline
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Event-Based Hospital VisibilityEPCIS in Hospitals
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Considerations on applications of EPCIS for…• Operating theatre events• Bedside events• Administration of pharmaceuticals
• Automated pre-procedure checks for:• Expired and recalled products• Verification that procedure can be performed• Verification of correct medical devices
• `
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Clearing up misconceptions on EPCIS
EPCIS is . . .• an open GS1 & ISO technical standard• an enabler for traceability solutions & services• data-carrier-neutral, suited to GS1 DataMatrix
EPCIS is not . . .• an out-of the box solution• a standalone answer to visibility issues
Serialization & event-based traceability will fundamentally change how a supply chain works... EPCIS will support this
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For further information on EPCIS…
Craig Alan Repec GS1 Global Office Senior Manager, Supply Chain Visibility, EPCIS & RFID+32 2 788 78 [email protected]
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GS1 Healthcare Resources
GS1 Healthcare: http://www.gs1.org/healthcare
Public Policy: http://www.gs1.org/public-policy/industry-sectors/healthcare
AIDC: http://www.gs1.org/healthcare/standards
GDSN: http://www.gs1.org/healthcare/share-data-gdsn
EDI: http://www.gs1.org/healthcare/share-data-edi
Traceability: http://www.gs1.org/traceability-healthcare
Case Studies: http://www.gs1.org/industries/healthcare/case-studies
Join: http://www.gs1.org/healthcare/membership
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